Docetaxel Injection
Product Images NDC 68083-401

17 FDA label images from Gland Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Docetaxel (NDC 68083-401). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gland Pharma Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Docetaxel-injection-spl-carton-16ml (Docetaxel Injection Spl Carton 16ml)

Docetaxel-injection-spl-carton-16ml (Docetaxel Injection Spl Carton 16ml)
Docetaxel Injection, USP 160 mg/16 mL (10 mg/mL) multi-dose vial carton label. Ready to add to infusion solution for intravenous use only. Contains cytotoxic agent warning and storage instructions. Manufactured by Gland Pharma Limited, Visakhapatnam, India. Includes NDC 68083-401-01 and barcode.*
FDA Label Image

Docetaxel-injection-spl-carton-2ml (Docetaxel Injection Spl Carton 2ml)

Docetaxel-injection-spl-carton-2ml (Docetaxel Injection Spl Carton 2ml)
Packaging label for Docetaxel Injection, USP 20 mg/2 mL (10 mg/mL) intravenous infusion solution. The single-dose vial contains 2 mL and is ready to add to infusion solution. Label indicates that the product is cytotoxic, sterile, and manufactured by Gland Pharma Limited, India. The label includes storage instructions and warnings to keep out of reach of children.*
FDA Label Image

Docetaxel-injection-spl-carton-8ml (Docetaxel Injection Spl Carton 8ml)

Docetaxel-injection-spl-carton-8ml (Docetaxel Injection Spl Carton 8ml)
Packaging label for Docetaxel Injection, USP 80 mg/8 mL (10 mg/mL) intravenous injection by Gland Pharma Limited. The label states it is a ready-to-add infusion solution in a multi-dose vial, includes caution for cytotoxicity, storage instructions, and warnings to keep out of reach of children. The label also includes the NDC 68083-400-01 and a barcode.*
FDA Label Image

Docetaxel-injection-spl-container-16ml (Docetaxel Injection Spl Container 16ml)

Docetaxel-injection-spl-container-16ml (Docetaxel Injection Spl Container 16ml)
Label for Docetaxel Injection, USP 160 mg per 16 mL (10 mg/mL) multi-dose vial by Gland Pharma Limited. Intended for intravenous infusion only, the label includes drug concentration, preparation instructions, a caution that it is a cytotoxic agent, storage conditions, and manufacturer details.*
FDA Label Image

Docetaxel-injection-spl-container-2ml (Docetaxel Injection Spl Container 2ml)

Docetaxel-injection-spl-container-2ml (Docetaxel Injection Spl Container 2ml)
Label for Docetaxel Injection USP, 20 mg per 2 mL (10 mg/mL) dosage form in a 2 mL single-dose vial. The label indicates intravenous infusion use only and cautions that it is a cytotoxic agent. Manufactured by Gland Pharma Limited in India, the label includes storage instructions and preparation warnings.*
FDA Label Image

Docetaxel-injection-spl-container-8ml (Docetaxel Injection Spl Container 8ml)

Docetaxel-injection-spl-container-8ml (Docetaxel Injection Spl Container 8ml)
Label for Docetaxel Injection, USP 80 mg/8 mL (10 mg/mL) multi-dose vial by Gland Pharma Limited. The label specifies intravenous infusion use, concentration details, and cautions including cytotoxic agent warning. It includes storage instructions, formulation info, and manufacturer details with a barcode present.*
FDA Label Image

Docetaxel-injection-spl-figure-10 (Docetaxel Injection Spl Figure 10)

Docetaxel-injection-spl-figure-10 (Docetaxel Injection Spl Figure 10)
A survival probability chart comparing two groups labeled TPF (n=255) and PF (n=246) over a 72-month survival time in months. The survival probability percentage is plotted on the vertical axis, showing a decline over time with TPF maintaining higher survival probabilities than PF. The number of patients at risk is listed below the horizontal axis at various time points.*
FDA Label Image

Docetaxel-injection-spl-figure-3 (Docetaxel Injection Spl Figure 3)

Docetaxel-injection-spl-figure-3 (Docetaxel Injection Spl Figure 3)
A Kaplan-Meier survival curve chart comparing cumulative survival probability over time in months between T75 and BSC groups. The solid line represents T75, and the dashed line represents BSC, with T75 showing higher survival probability. The chart includes a log-rank p value of 0.010 for overall survival.*
FDA Label Image

Docetaxel-injection-spl-figure-4 (Docetaxel Injection Spl Figure 4)

Docetaxel-injection-spl-figure-4 (Docetaxel Injection Spl Figure 4)
A survival curve chart comparing cumulative probability over survival time in months between two groups labeled T75 (solid line) and V/I (dashed line). The x-axis represents survival time up to 21 months, and the y-axis represents cumulative probability from 0.0 to 1.0. The chart includes a statistical reference to overall survival with a log-rank p-value of 0.13.*
FDA Label Image

Docetaxel-injection-spl-figure-5 (Docetaxel Injection Spl Figure 5)

Docetaxel-injection-spl-figure-5 (Docetaxel Injection Spl Figure 5)
A survival probability curve comparing two treatment groups labeled as T75 q3w and M q3w over a period of 30 months. The vertical axis shows survival probability from 0 to 1.0, and the horizontal axis indicates survival time in months from 0 to 30.*
FDA Label Image

Docetaxel-injection-spl-figure-6 (Docetaxel Injection Spl Figure 6)

Docetaxel-injection-spl-figure-6 (Docetaxel Injection Spl Figure 6)
A Kaplan-Meier survival curve showing probability (%) over time in months for two treatment groups labeled TCF and CF. The graph illustrates survival probabilities for both groups up to 24 months, with TCF consistently showing higher survival probabilities than CF.*
FDA Label Image

Docetaxel-injection-spl-figure-7 (Docetaxel Injection Spl Figure 7)

Docetaxel-injection-spl-figure-7 (Docetaxel Injection Spl Figure 7)
A survival probability curve chart comparing two treatment groups labeled TCF and CF over a 36-month period. The y-axis represents survival probability (%) from 0 to 100, and the x-axis shows survival time in months from 0 to 36. Both curves decline over time, illustrating decreasing survival probabilities.*
FDA Label Image

Docetaxel-injection-spl-figure-8 (Docetaxel Injection Spl Figure 8)

Docetaxel-injection-spl-figure-8 (Docetaxel Injection Spl Figure 8)
A Kaplan-Meier survival curve chart showing Progression-Free Survival (PFS) Probability over time in months. The chart compares two groups labeled TPF and PF, illustrating their PFS probabilities across a period extending to 42 months.*
FDA Label Image

Docetaxel-injection-spl-figure-9 (Docetaxel Injection Spl Figure 9)

Docetaxel-injection-spl-figure-9 (Docetaxel Injection Spl Figure 9)
A survival probability curve chart showing two survival time groups in months along the x-axis, with survival probability percentage on the y-axis. The chart compares the survival probability of two groups labeled TPF and PF over a period up to 72 months.*
FDA Label Image

Docetaxel-injection-spl-structure (Docetaxel Injection Spl Structure)

Docetaxel-injection-spl-structure (Docetaxel Injection Spl Structure)
Chemical structure diagram of Docetaxel, showing the detailed molecular arrangement of atoms and bonds in the active pharmaceutical ingredient Docetaxel.*
FDA Label Image

Docetaxel-injection-spl-figure-1 (Docetaxel Injection Spl Figure 1)

Docetaxel-injection-spl-figure-1 (Docetaxel Injection Spl Figure 1)
A Kaplan-Meier curve titled 'TAX316 Disease Free Survival K-M Curve' showing disease-free survival probability over time in months. The y-axis is labeled 'DFS Probability (%)' ranging from 0 to 100, and the x-axis represents disease-free survival time from 0 to 66 months. Two survival curves are displayed, labeled 'TAC' and 'FAC', demonstrating survival trends over time.*
FDA Label Image

Docetaxel-injection-spl-figure-2 (Docetaxel Injection Spl Figure 2)

Docetaxel-injection-spl-figure-2 (Docetaxel Injection Spl Figure 2)
A Kaplan-Meier curve titled 'TAX316 Overall Survival K-M Curve' showing survival probability (%) over survival time in months. It compares two groups, labeled TAC and FAC, with survival probabilities decreasing over time for both groups.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.